Alcohol Use Disorder (AUD)SIMAiRNCT07474207
Social Identity Mapping for Adolescent Recovery
A study testing SIM-AiR in people with Alcohol Use Disorder (AUD), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to address the gap between clinical treatment and adolescents' lived social environments by developing and testing a novel, interactive intervention-SIM-AiR-that directly targets social risk and protective factors. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- SIM-AiR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligible participants are adolescents (ages 12-19) enrolled as outpatient clients at an addiction treatment facility.
- Meet criteria for alcohol use disorder (mild to severe) as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V).
- Be able to speak, read, and understand English.
Who cannot join
- Refusal to give informed consent, or if under 18 years old, do not have a parent willing for them to consent to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Recovery Research Institute; National Center on Youth Prevention, Treatment, & Recovery; Harvard Medical School
Boston, Massachusetts, 02114
Emily A Hennessy, PhD, 9784730222, ehennessy@mgh.harvard.edu
Emily A Hennessy, PhD
About this study
The goal of this clinical trial is to address the gap between clinical treatment and adolescents' lived social environments by developing and testing a novel, interactive intervention-SIM-AiR-that directly targets social risk and protective factors. By helping youth visually and cognitively process their social identities and networks, SIM-AiR seeks to support more enduring recovery outcomes in adolescents (12-19 years old) with alcohol use disorder (AUD). The specific aims of this study protocol are to pilot the SIM-AiR intervention module and collect participant acceptability feedback and preliminary outcomes. The main questions it aims to answer are:
What is the acceptability of the SIM-AiR treatment module from the perspective of participants? Do participants' acceptability ratings of the SIM-AiR treatment module vary by personal and/or social network characteristics?
Clinicians will implement the SIM-AiR with an adolescent client. Clinicians will provide feedback to the study team on their experience to support future implementation. Participants will complete the SIM-AiR module during a treatment session with their clinician and participate in data collection with study staff (e.g., surveys, interviews) following the treatment session.
Read the detailed description
- Specific Aims and Objectives The specific aims of this study protocol are to pilot the SIM-AiR intervention module with 60 adolescents (12-19 years old) with alcohol use disorder (AUD) and collect patient acceptability feedback and preliminary outcomes. 60 adolescents receiving outpatient AUD treatment will be recruited to receive the SIM-AiR module and to participate in study visit to collect acceptability information.
- General Description of Study Design This is Aim 2 of the R34 grant proposal, which is an intervention development grant. Aim 1 of this grant is pilot work directly with clinicians to finalize the treatment module. The SIM-AiR module will be incorporated as a single session for patients attending adolescent outpatient treatment program. In line with the aims of this as a pilot project, investigators will recruit clinicians to pilot the SIM-AiR and then our study team will conduct a single study visit with the clinician to get their feedback and with the adolescent to collect their acceptability feedback and other characteristics to consider necessary steps adaptation for implementation in a future larger clinical trial. As a pilot study, our focus will be on recruiting adolescents already seeking AUD treatment.
- Study Procedures After the adolescent participant has consented, the participant will be able to schedule their intervention session and study visit. The clinician will deliver the SIM-AiR in an individual treatment session with an adolescent client that will occur sometime after their initial treatment session. The session will be audio-recorded for fidelity. After each session, clinicians will be asked to complete an online survey about their immediate impressions of implementing the SIM-AiR with their client. The participant will also complete an interview after the first implementation of SIM-AiR to get immediate feedback on any areas that need to be adapted for future implementation. As clinicians conduct more SIM-AiR sessions study staff will conduct interviews, as necessary, to collect any new feedback on the procedure and materials. The adolescent participant will also be scheduled to participate in data collection following the treatment session with a member of the study team. A subset of adolescents will be selected for the interview. For those clients, the survey will be followed by the brief, audio-recorded interview with a member of the study team. Description of intervention: The clinician would engage the adolescent participant in the activity of social identity mapping (SIM) and use that to have a discussion, using motivational interviewing principles, about their social networks and social influences (supports, barriers) for treatment and recovery. The SIM process involves posing a series of questions to produce a visual map of the individual within their social network using paper, markers, and stickers. The SIMs capture the following data: size of social network via the number of social groups represented, each group's importance to the individual, number of days/month spent with each group, one's level of identification with each group, level of conflict between self and each group and between each group with each other, level of commonality between self and each group and between each group with each other, alcohol and other drug use among group members, type of group. The clinician would follow the SIM process with a motivational-interviewing styled discussion to elicit reflections from the participant and specific action steps the participant can take in their recovery process when with members of their social network. Description of data variables to be collected: Adolescents will be asked to complete an electronic survey to capture psychosocial characteristics. Clinicians will also complete a brief survey and an interview.
- Statistical Analysis
There is no plan to conduct interim or futility analyses given the pilot nature of the clinical trial. Alpha levels will be adjusted as appropriate depending on whether preliminary analyses or reviews of collected data are done, as well as when conducting any confirmatory a priori-specified analyses. The analysis will examine the acceptability of the SIM-AiR from the adolescent perspective by their Treatment Satisfaction score. In addition, distributions, descriptive statistics, and correlations for all survey measures will be examined including components from the SIM (i.e., number of groups, importance of groups, and sober versus substance-using groups; degree of importance and identification with low- and high-risk groups) to examine whether a participant's acceptability rating of the SIM-AiR varies by personal and/or social network characteristics. The analysis will take descriptive qualitative and constant comparative approaches to examine major themes related to the acceptability of the SIM-AiR module.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- SIM-AiR
- Keywords
- Social network, Social Identity Mapping, Alcohol use disorder, Treatment, Addiction recovery, Adolescents
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM-AiRBehavioural
Also called SIM, Social Identity Mapping
The clinician would engage the adolescent participant in the activity of social identity mapping (SIM) and use that to have a discussion, using motivational interviewing principles, about their social networks and social influences (supports, barriers) to treatment and recovery. The SIM process involves posing a series of questions to produce a visual map of the individual within their social network using paper, markers, and stickers. As this is a pilot study, this will be done once.
| Study group | Role | What they receive |
|---|---|---|
| SIM-AiR | Experimental | As this is a single arm study, all participants will receive the SIM-AiR treatment module. Receives: Behavioral: SIM-AiR |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIM-AiR Acceptability (Treatment satisfaction)
The acceptability of the SIM-AiR module from adolescents' perspectives will be assessed using the validated Treatment Satisfaction scale. Participants will answer 5 questions on a likert scale of (1) 'Strongly disagree' to (5) 'Strongly agree'. Scores range from 5-25, with higher scores indicating a greater satisfaction with the SIM-AiR module.
Measured: Baseline
SIM-AiR Acceptability (Adolescent Treatment Engagement: Counseling Rapport sub scale)
The acceptability of the SIM-AiR module from adolescents' perspectives will be assessed using the validated Counseling Rapport sub scale of the TCU Adolescent Engagement Form. Participants will answer 11 questions on a likert scale of (1) 'Strongly disagree' to (5) 'Strongly agree'. Scores range from 10-50, with higher scores indicating a greater rapport with the treatment counselor.
Measured: Baseline
SIM-AiR Acceptability (Acceptability of Intervention Measure)
The acceptability of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Acceptability of Intervention Measure (AIM). Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'. Scores range from 4-20, with higher scores indicating a greater perceived acceptability of the SIM-AiR as a treatment module.
Measured: Baseline
SIM-AiR Appropriateness (Intervention Appropriateness Measure)
The appropriateness of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Intervention Appropriateness Measure (IAM). Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'. Scores range from 4-20, with higher scores indicating a greater perceived appropriateness of the SIM-AiR as a treatment module.
Measured: Baseline
SIM-AiR Feasibility (Feasibility of Intervention Measure)
The feasibility of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Feasibility of Intervention Measure (FIM). Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'. Scores range from 4-20, with higher scores indicating a greater perceived feasibility of the SIM-AiR as a treatment module.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Connecticut
- Responsible party
- Principal investigator, Emily Hennessy, Massachusetts General Hospital
- Investigators
- Emily A Hennessy, PhD, Principal investigator, Recovery Research Institute; National Center on Youth Prevention, Treatment, & Recovery; Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474207
- Sponsor's protocol ID
- 2025P001514
- Other IDs
- 1R34AA032288-01
- Acronym
- SIMAiR
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the size of the trial and the proposed participant sample, the potential risks to breaches of confidentiality are too great.
Publications
Jurinsky J, Cowie K, Blyth S, Hennessy EA. "A lot better than it used to be": A qualitative study of adolescents' dynamic social recovery capital. Addict Res Theory. 2023;31(2):77-83. doi: 10.1080/16066359.2022.2114076. Epub 2022 Aug 29.
PubMed 37008756Hennessy EA, Jurinsky J, Cowie K, Pietrzak AZ, Blyth S, Krasnoff P, Best D, Litt M, Johnson BT, Kelly JF. Visualizing the Influence of Social Networks on Recovery: A Mixed-Methods Social Identity Mapping Study with Recovering Adolescents. Subst Use Misuse. 2024;59(9):1405-1415. doi: 10.1080/10826084.2024.2352618. Epub 2024 May 13.
PubMed 38738809Blyth SH, Pietrzak A, Rodriguez WA, Litt MD, Kelly JF, Hennessy EA. A Qualitative Examination of Addiction Disclosure and Stigma among Recovering Adolescents. Addict Res Theory. 2025;33(4):286-293. doi: 10.1080/16066359.2024.2431598. Epub 2024 Nov 28.
PubMed 40785814
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Identity Mapping for Adolescent Recovery
- ClinicalTrials.gov ID
- NCT07474207
- Acronym / sponsor ID
- SIMAiR / 2025P001514
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Social network, Social Identity Mapping, Alcohol use disorder, Treatment, Addiction recovery, Adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Connecticut
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to address the gap between clinical treatment and adolescents' lived social environments by developing and testing a novel, interactive intervention-SIM-AiR-that directly targets social risk and protective factors. By helping youth visually and cognitively process their social identities and networks, SIM-AiR seeks to support more enduring recovery outcomes in adolescents (12-19 years old) with alcohol use disorder (AUD). The specific aims of this study protocol are to pilot the SIM-AiR intervention module and collect participant acceptability feedback and preliminary outcomes. The main questions it aims to answer are:
What is the acceptability of the SIM-AiR treatment module from the perspective of participants? Do participants' acceptability ratings of the SIM-AiR treatment module vary by personal and/or social network characteristics?
Clinicians will implement the SIM-AiR with an adolescent client. Clinicians will provide feedback to the study team on their experience to support future implementation. Participants will complete the SIM-AiR module during a treatment session with their clinician and participate in data collection with study staff (e.g., surveys, interviews) following the treatment session.
Detailed description
- Specific Aims and Objectives The specific aims of this study protocol are to pilot the SIM-AiR intervention module with 60 adolescents (12-19 years old) with alcohol use disorder (AUD) and collect patient acceptability feedback and preliminary outcomes. 60 adolescents receiving outpatient AUD treatment will be recruited to receive the SIM-AiR module and to participate in study visit to collect acceptability information.
- General Description of Study Design This is Aim 2 of the R34 grant proposal, which is an intervention development grant. Aim 1 of this grant is pilot work directly with clinicians to finalize the treatment module. The SIM-AiR module will be incorporated as a single session for patients attending adolescent outpatient treatment program. In line with the aims of this as a pilot project, investigators will recruit clinicians to pilot the SIM-AiR and then our study team will conduct a single study visit with the clinician to get their feedback and with the adolescent to collect their acceptability feedback and other characteristics to consider necessary steps adaptation for implementation in a future larger clinical trial. As a pilot study, our focus will be on recruiting adolescents already seeking AUD treatment.
- Study Procedures After the adolescent participant has consented, the participant will be able to schedule their intervention session and study visit. The clinician will deliver the SIM-AiR in an individual treatment session with an adolescent client that will occur sometime after their initial treatment session. The session will be audio-recorded for fidelity. After each session, clinicians will be asked to complete an online survey about their immediate impressions of implementing the SIM-AiR with their client. The participant will also complete an interview after the first implementation of SIM-AiR to get immediate feedback on any areas that need to be adapted for future implementation. As clinicians conduct more SIM-AiR sessions study staff will conduct interviews, as necessary, to collect any new feedback on the procedure and materials. The adolescent participant will also be scheduled to participate in data collection following the treatment session with a member of the study team. A subset of adolescents will be selected for the interview. For those clients, the survey will be followed by the brief, audio-recorded interview with a member of the study team. Description of intervention: The clinician would engage the adolescent participant in the activity of social identity mapping (SIM) and use that to have a discussion, using motivational interviewing principles, about their social networks and social influences (supports, barriers) for treatment and recovery. The SIM process involves posing a series of questions to produce a visual map of the individual within their social network using paper, markers, and stickers. The SIMs capture the following data: size of social network via the number of social groups represented, each group's importance to the individual, number of days/month spent with each group, one's level of identification with each group, level of conflict between self and each group and between each group with each other, level of commonality between self and each group and between each group with each other, alcohol and other drug use among group members, type of group. The clinician would follow the SIM process with a motivational-interviewing styled discussion to elicit reflections from the participant and specific action steps the participant can take in their recovery process when with members of their social network. Description of data variables to be collected: Adolescents will be asked to complete an electronic survey to capture psychosocial characteristics. Clinicians will also complete a brief survey and an interview.
- Statistical Analysis
There is no plan to conduct interim or futility analyses given the pilot nature of the clinical trial. Alpha levels will be adjusted as appropriate depending on whether preliminary analyses or reviews of collected data are done, as well as when conducting any confirmatory a priori-specified analyses. The analysis will examine the acceptability of the SIM-AiR from the adolescent perspective by their Treatment Satisfaction score. In addition, distributions, descriptive statistics, and correlations for all survey measures will be examined including components from the SIM (i.e., number of groups, importance of groups, and sober versus substance-using groups; degree of importance and identification with low- and high-risk groups) to examine whether a participant's acceptability rating of the SIM-AiR varies by personal and/or social network characteristics. The analysis will take descriptive qualitative and constant comparative approaches to examine major themes related to the acceptability of the SIM-AiR module.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIM-AiR | Experimental | Behavioral: SIM-AiRAs this is a single arm study, all participants will receive the SIM-AiR treatment module. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Eligible participants are adolescents (ages 12-19) enrolled as outpatient clients at an addiction treatment facility.
- Meet criteria for alcohol use disorder (mild to severe) as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V).
- Be able to speak, read, and understand English.
Key exclusion criteria (1 listed)
- Refusal to give informed consent, or if under 18 years old, do not have a parent willing for them to consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM-AiRAlso: SIM, Social Identity MappingThe clinician would engage the adolescent participant in the activity of social identity mapping (SIM) and use that to have a discussion, using motivational interviewing principles, about their social networks and social influences (supports, barriers) to treatment and recovery. The SIM process involves posing a series of questions to produce a visual map of the individual within their social network using paper, markers, and stickers. As this is a pilot study, this will be done once. | Behavioural | SIM-AiR |
Primary outcome
SIM-AiR Acceptability (Treatment satisfaction)
Time frame: Baseline
The acceptability of the SIM-AiR module from adolescents' perspectives will be assessed using the validated Treatment Satisfaction scale. Participants will answer 5 questions on a likert scale of (1) 'Strongly disagree' to (5) 'Strongly agree'. Scores range from 5-25, with higher scores indicating a greater satisfaction with the SIM-AiR module.
SIM-AiR Acceptability (Adolescent Treatment Engagement: Counseling Rapport sub scale)
Time frame: Baseline
The acceptability of the SIM-AiR module from adolescents' perspectives will be assessed using the validated Counseling Rapport sub scale of the TCU Adolescent Engagement Form. Participants will answer 11 questions on a likert scale of (1) 'Strongly disagree' to (5) 'Strongly agree'. Scores range from 10-50, with higher scores indicating a greater rapport with the treatment counselor.
SIM-AiR Acceptability (Acceptability of Intervention Measure)
Time frame: Baseline
The acceptability of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Acceptability of Intervention Measure (AIM). Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'. Scores range from 4-20, with higher scores indicating a greater perceived acceptability of the SIM-AiR as a treatment module.
SIM-AiR Appropriateness (Intervention Appropriateness Measure)
Time frame: Baseline
The appropriateness of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Intervention Appropriateness Measure (IAM). Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'. Scores range from 4-20, with higher scores indicating a greater perceived appropriateness of the SIM-AiR as a treatment module.
SIM-AiR Feasibility (Feasibility of Intervention Measure)
Time frame: Baseline
The feasibility of the SIM-AiR module from clinicians' perspectives will be assessed using the validated Feasibility of Intervention Measure (FIM). Clinicians will answer 4 questions on a likert scale of (1) 'Completely disagree' to (5) 'Completely agree'. Scores range from 4-20, with higher scores indicating a greater perceived feasibility of the SIM-AiR as a treatment module.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 37008756Jurinsky J, Cowie K, Blyth S, Hennessy EA. "A lot better than it used to be": A qualitative study of adolescents' dynamic social recovery capital. Addict Res Theory. 2023;31(2):77-83. doi: 10.1080/16066359.2022.2114076. Epub 2022 Aug 29.
- Background: PubMed 38738809Hennessy EA, Jurinsky J, Cowie K, Pietrzak AZ, Blyth S, Krasnoff P, Best D, Litt M, Johnson BT, Kelly JF. Visualizing the Influence of Social Networks on Recovery: A Mixed-Methods Social Identity Mapping Study with Recovering Adolescents. Subst Use Misuse. 2024;59(9):1405-1415. doi: 10.1080/10826084.2024.2352618. Epub 2024 May 13.
- Background: PubMed 40785814Blyth SH, Pietrzak A, Rodriguez WA, Litt MD, Kelly JF, Hennessy EA. A Qualitative Examination of Addiction Disclosure and Stigma among Recovering Adolescents. Addict Res Theory. 2025;33(4):286-293. doi: 10.1080/16066359.2024.2431598. Epub 2024 Nov 28.
- Individual participant dataSharing planned: No. Given the size of the trial and the proposed participant sample, the potential risks to breaches of confidentiality are too great.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily A Hennessy, PhD principal investigator
Recovery Research Institute; National Center on Youth Prevention, Treatment, & Recovery; Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIM-AiR in people with Alcohol Use Disorder (AUD), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaden Femrite (978-473-0222, jfemrite@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIM-AiR Acceptability (Treatment satisfaction) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474207, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.